China NMPA Issues 2026 Medical Device Industry Standards Development and Revision Plan

On February 11, 2026, the National Medical Products Administration (NMPA) published “Notice on Issuing the 2026 Medical Device Industry Standards Development and Revision Plan” on its official website. The plan outlines the development and revision of more than 80 medical device industry standards, including mandatory standards, recommended standards, and foreign-language versions, with direct implications for China medical device registration and NMPA compliance strategies.

Scope of the 2026 Medical Device Standards Plan

The 2026 plan is designed to strengthen China’s medical device standards framework, improve technical rigor, and further align domestic requirements with international standards such as ISO.

Specifically, the plan includes:

• 1 mandatory industry standard
• 79 recommended industry standards
• 2 official English-language versions of existing Chinese standards

Taken together, these measures signal a continued shift toward deeper technical harmonization and structured regulatory modernization. For overseas manufacturers, this means moving beyond baseline market entry compliance toward proactive alignment with evolving China medical device regulation requirements.

Mandatory Industry Standard: Dentistry — Water-Based Cements

The 2026 plan contains one mandatory industry standard:

Dentistry — Water-Based Cements — Part 1: Acid-Base Cements

This revision adopts ISO 9917-1:2025 and replaces YY 0271.1—2016. By directly incorporating the latest ISO edition, the NMPA further aligns mandatory dental material requirements with international benchmarks.

For manufacturers of dental restorative materials, compliance with the updated ISO-aligned technical requirements will be essential for both new NMPA medical device registration and the ongoing maintenance of existing certificates. Companies should assess formulation testing, performance validation, and supporting technical documentation against the revised standard.

Recommended Industry Standards Across Key Technical Fields

In addition to the mandatory update, the plan introduces 79 recommended standards spanning both emerging technologies and established product categories.

Although recommended standards are not legally binding by default, they frequently become de facto technical references during product testing and registration review. As a result, early alignment can reduce technical deficiencies and streamline review timelines.

The standards cover areas such as:

• Tissue engineering and regenerative medicine
• Artificial intelligence and medical robotics
• In vitro diagnostics and precision medicine
• Advanced imaging and radiotherapy equipment
• Surgical implants and cardiovascular devices
• Digital dentistry and related technologies

This broad scope reflects regulatory attention to innovation-driven sectors while reinforcing foundational safety and performance requirements.

Click here for a detailed breakdown of the individual standards.

Development of Official English Versions of Chinese Standards

To support internationalization, the NMPA will publish official English versions of two existing industry standards:

1. Gene Mutation Detection Kit for Tumor Tissue (High-Throughput Sequencing Method)
   Corresponding Chinese version: YY/T 1946—2024
2. Software for Chromosome Aneuploidy Analysis in Human Embryo Preimplantation Genetic Testing
   Corresponding Chinese version: YY/T 1968—2025

The release of authoritative English texts reduces interpretation risk for overseas applicants and facilitates technical alignment during dossier preparation.

Next Steps for Overseas Manufacturers

Foreign Overseas manufacturers should treat the 2026 plan as an early regulatory intelligence signal rather than waiting for formal implementation dates. A phased and structured response will reduce transition risk and protect ongoing China market access.

Conduct Intelligence Screening (March–April 2026)

Between March and April 2026, companies should download and review the complete official standards list and establish an internal “affected products” matrix. Particular attention should be given to:

• Newly established standards without historical references
• Revisions adopting updated ISO editions
• Standards affecting high-risk Class III products

Advance Technical Preparation (Throughout 2026)

Following screening, technical preparation should begin well before final publication. Key actions include:

• ISO benchmarking: For revised standards adopting the latest ISO versions (e.g., dentistry, surgical implant coatings, medical suction devices), conduct a direct gap analysis against the newest ISO edition.
• Methodology research: For newly established standards without previous reference numbers (e.g., heart valve clip fatigue testing, biodegradable microparticle evaluations), proactively contact responsible Chinese institutions (such as dental inspection centers in Tianjin, Shandong, and Beijing) to clarify methodologies through technical exchange.

The objective is to complete pre-emptive updates to technical documentation, risk management files, and validation data.

Plan Compliance Implementation After Publication

After official issuance of finalized standards, assess whether:

• Change registration applications are required for existing NMPA certificates
• Re-registration will be triggered
• New products should directly adopt the latest standards to avoid transition risk

Early voluntary alignment with recommended standards may strengthen registration submissions and reduce review deficiencies.

Final Thoughts

The 2026 Medical Device Industry Standards Development and Revision Plan reinforce China’s continued push toward ISO harmonization, AI oversight, and more stringent technical and preclinical evaluation requirements.

For international manufacturers, compliance is increasingly forward-looking. New and revised standards may affect product validation, testing methodologies, and existing NMPA certificates — potentially triggering change filings or review delays if not addressed early.

In this environment, a structured regulatory response is critical. Through targeted standard gap analysis, strategic NMPA registration planning, and coordination with qualified Chinese testing institutes, Cisema helps overseas manufacturers align documentation and performance data with evolving requirements and protect uninterrupted access to the China market. For a structured assessment of how the 2026 standards plan may impact your product portfolio, contact Cisema today.

Further Information

• For an overview of regulatory pathways and technical support options, explore Cisema’s services for China NMPA medical device registration.

References

• Official source: “国家药监局综合司关于印发2026年医疗器械行业标准制修订计划项目的通知 药监综械注〔2026〕17号,” (Notice of the General Department of the State Food and Drug Administration on printing and distributing the 2026 medical device industry standard formulation and revision plan project).

Appendix — Selected Recommended Standards Under the 2026 Plan

Artificial Intelligence and Medical Robotics

Standard TitleMain Technical Content / Adopted Standard[New] AI Medical Devices — Dataset-Specific Requirements: Electrocardiogram (ECG)Specifies data quality, annotation standards, and dataset-specific requirements for ECG AI datasets[New] Medical Electrical Equipment Using Robotic Technology — Requirements and Test Methods for Electromagnetic Surgical Navigation SystemsSpecifies performance requirements, electromagnetic compatibility, and safety test methods for electromagnetic navigation surgical robots[New] Steep Pulse Therapy EquipmentDefines output characteristics, safety indicators, and performance validation methods for steep pulse ablation technology[Revision] Electromyography (EMG) Biofeedback DevicesUpdates technical requirements and test methods; replaces YY/T 1095—2015

In Vitro Diagnostics (IVD) and Precision Medicine

Standard TitleMain Technical Content / Adopted Standard[New] Detection Kit for Mycobacterium Tuberculosis Complex and Drug Resistance Gene MutationsSpecifies performance indicators and validation methods for drug resistance gene detection kits[Revision] Free Prostate-Specific Antigen (fPSA) Assay KitUpdates technical requirements; replaces YY/T 1249—2014[New] Technical Guideline for High-Throughput Sequencing Analysis of Tumor Microsatellite InstabilityStandardizes NGS analysis workflow and data interpretation for MSI testing[New] Technical Requirements for Metagenomic Sequencing in Bloodstream Infection Pathogen DetectionEstablishes requirements for sample processing, sequencing, and data analysis for mNGS[New] Cybersecurity Risk Considerations and Testing Guidelines for Gene SequencersProposes a cybersecurity risk assessment framework and testing methods for gene sequencers[New] Fully Automated Gene Sequencing Library Preparation SystemSpecifies functional, performance, and validation requirements[New] IVD Medical Devices — Implementation Guide for Establishing Metrological Traceability — Part 2: Traceability to Internationally Agreed Calibrators or Harmonized Reference MaterialsProvides implementation guidance for traceability to international reference materials[New] IVD Medical Devices — Implementation Guide for Establishing Metrological Traceability — Part 3: Traceability to Manufacturer-Defined Internal Reference MaterialsProvides implementation guidance for traceability to manufacturer-defined internal reference materials[New] Valproic Acid Assay KitEstablishes methodology and performance requirements[New] Renin Assay Kit (Chemiluminescent Immunoassay)Establishes methodology and performance requirements[New] Rheumatoid Factor Assay KitEstablishes methodology and performance requirements[New] α1-Microglobulin Assay Kit (Immunoturbidimetry)Establishes methodology and performance requirements[New] Free Estriol Assay Kit (Labeled Immunoassay)Establishes methodology and performance requirements[New] Gastrin-17 Assay Kit (Labeled Immunoassay)Establishes methodology and performance requirements[New] Thromboelastography AnalyzerSpecifies technical requirements and test methods for coagulation function analyzers

Medical Imaging and Radiotherapy Equipment

Standard TitleMain Technical Content / Adopted Standard[Revision] Positron Emission and X-ray Computed Tomography System — Performance and Test MethodsRevises PET/CT performance test methods; replaces YY/T 0829—2011[Revision] Single Photon Emission and X-ray Computed Tomography System — Performance and Test MethodsUpdates SPECT/CT performance evaluation standards; replaces YY/T 1408—2016[New] Medical Magnetic Resonance Imaging Equipment — Determination of Spectroscopy Quality ParametersEstablishes quality evaluation indicators and test methods for MRS[Revision] Dedicated Technical Requirements for Digital Radiography (DR) X-ray SystemsUpdates dedicated requirements; replaces YY/T 0741—2018[New] X-ray Computed Tomography Equipment Image Quality Evaluation Method — Part 5: Temporal Resolution EvaluationEstablishes CT temporal resolution evaluation method[New] Ultrasonic Surgical AspiratorSpecifies dedicated requirements[New] General Technical Requirements for Intracardiac Ultrasound Diagnostic EquipmentSpecifies dedicated requirements[New] Laser Therapy Equipment — Thulium-Doped Fiber Laser SystemSpecifies performance and safety requirements

Surgical Implants and Cardiovascular Devices

Standard TitleMain Technical Content / Adopted Standard[Revision] Joint Replacement Implant Instruments — Performance Evaluation Requirements for Knee ProsthesesUpdates evaluation indicators; replaces YY/T 0919—2014[New] Joint Replacement Implant Instruments — Radial Head SystemSpecifies dimensions, performance, and test methods[Revision] Cardiovascular Implants — Endovascular Devices — Part 3: Vena Cava FiltersAdopts ISO 25539-3:2024; replaces YY/T 0663.3—2016[New] Cardiovascular Implants — Fatigue Test Methods for Heart Valve Clip SystemsEstablishes durability test methods for transcatheter valve clip systems[Revision] Surgical Implants — Metallic Surgical Implant Coatings — Part 1: Plasma-Sprayed Coatings of Titanium or Titanium-6Aluminum-4Vanadium AlloyAdopts ISO 13179-1:2021; replaces YY/T 1706.1—2020[New] Surgical Implants — Implant Threads for Plastic SurgerySpecifies material, mechanical, and biological evaluation requirements

Dental Medical Devices

Standard TitleMain Technical Content / Adopted Standard[Revision] Dentistry — Maxillary Sinus Membrane ElevatorAdopts ISO 19490:2025; replaces YY/T 1693—2020[Revision] Dentistry — Dental ElevatorAdopts ISO 15087:2025; replaces YY/T 0170—2011[Revision] Dentistry — Dental Bone Filling MaterialsAdopts ISO 22794:2007; replaces YY/T 0525—2009[New] Preclinical Animal Evaluation Research for Dental Medical Devices — Evaluation Method for Osteogenic Performance of Dental Barrier MembranesEstablishes animal model evaluation method for osteogenic performance[New] Dentistry — Digitally Manufactured Titanium MeshSpecifies technical requirements and test methods

Other General and Auxiliary Equipment

Standard TitleMain Technical Content / Adopted Standard[Revision] Medical Suction Equipment — Part 1: Electrically Powered Suction EquipmentAdopts ISO 10079-1:2022; replaces YY/T 0636.1—2021[Revision] Medical Suction Equipment — Part 2: Manually Powered Suction EquipmentAdopts ISO 10079-2:2022; replaces YY/T 0636.2—2021[Revision] Medical Suction Equipment — Part 3: Suction Equipment Powered by Vacuum or Positive Pressure SourceAdopts ISO 10079-3:2022; replaces YY/T 0636.3—2021[New] Medical Suction Equipment — Part 4: General RequirementsAdopts ISO 10079-4:2021; specifies general requirements[New] Reliability Test and Verification Methods for Emergency VentilatorsSpecifies reliability validation procedures[New] Single-Use Laparoscopic Specimen Retrieval BagEstablishes new standard for minimally invasive surgical instruments[New] Barbed Surgical SuturesEstablishes new standard for minimally invasive surgical instruments[New] Vertebral Balloon Dilation CatheterSpecifies performance requirements[Revision] Disposable Centrifugal Blood Component SeparatorIntegrates YY 0613—2007 and YY 0584—2005; updates blood cell separator standards[New] Medical Polymer Products — Test Method for Ultrasound VisibilityEstablishes ultrasound imaging performance test method[New] Preclinical Animal Study of Medical Devices — Part 5: Rat Cecum–Abdominal Wall Adhesion Model for Evaluating Anti-Adhesion Products in Pelvic and Abdominal SurgeryStandardizes animal model for anti-adhesion product efficacy evaluation[Revision] Immunogenicity Evaluation Methods for Medical Devices — Part 1: In Vitro T Lymphocyte Transformation TestUpdates method; replaces YY/T 1465.1—2016[Revision] Standard Test Model for Performance Evaluation of Contact Wound Dressings — Part 2: Animal Burn Model for Evaluating Wound Healing PromotionUpdates burn model evaluation method; replaces YY/T 1477.2—2016[Revision] Preparation and Quality Management of Fluids for Hemodialysis and Related Therapies — Part 1: Water Treatment EquipmentAdopts ISO 23500-2:2024; replaces YY/T 0793.1—2022[Revision] Preparation and Quality Management of Fluids for Hemodialysis and Related Therapies — Part 4: Dialysate QualityAdopts ISO 23500-5:2024; replaces YY/T 0793.4—2022[Revision] Disposable Hemoperfusion DeviceUpdates standard; replaces YY/T 0464—2019[New] Reliability Modeling, Prediction, and Allocation Methods for Active Medical DevicesProvides methodological guidance for reliability analysis[Revision] StethoscopeUpdates technical requirements; replaces YY/T 1035—2021[Revision] Test Methods for Sterile Medical Device Packaging — Part 1: Accelerated Aging Test GuideUpdates guide; replaces YY/T 0681.1—2018[Revision] Test Methods for Sterile Medical Device Packaging — Part 17: Microbial Barrier Test for Porous Packaging Materials Using Aerosol Filtration MethodUpdates microbial barrier test method; replaces YY/T 0681.17—2019